I just read your post [on augmented cognition] and found it intriguing. I have been experimenting with a nutritional supplement for the past several years which was designed to treat bi-polar disorder (and it works amazing well for that purpose according to all the researchers who have studied it) and have found my capacity to hold way more information (and not go crazy) and maintain my calmness under pressure is greatly expanded.

Some of the rat research neuro-anatomist guys have regrown frontal cortexes in lobotomized rats fed the product and in blinded microscopic studies of brain slices have determined a 3 to 4 fold increase in dentritic and synapic receptors/connections.

The fellows who invented the product have become personal friends so I treat the drug industry sponsored attacks on them with suspicion. Check out truehope.com

Best,

Peter Helgason

Canada

I copied the message directly from my email account, so the mistakes are down to Mr. Helgason and not me.

The miraculous remedy that Helgason refers to, which not only alleviates the symptoms of bipolar disorder, but also acts as a sedative, enhances memory, stimulates neuron and axonal regeneration and upregulates expression of receptor genes is a “nutraceutical” called EM Power+ (or E. M. Power Plus).

TrueHope (aka Synergy), the Canadian company that produces the supplement, have apparently never conducted randomized clinical trials to determine the efficacy and safety of their treatment. There is therefore no evidence that this supplement is in any way beneficial – or safe – for patients with bipolar disorder or any other condition.

Comments

As someone who actually suffers from bipolar disorder, these altie-med quacks piss me off in an extra special way. I know first-hand what refraining from treatment can do your emotional and psychological state, and to see idiots market this bullshit to vulnerable people makes me angry enough to saw my arms off.

Actually, according to this article there have been some preliminary studies on efficacy with positive results. The article is from 2005, and mentioned that two of the researchers (neither have any association with the firm marketing the produc) who did (and published) preliminary studies had secured approval for a larger clinical study.

I haven’t been able to find out if that study was conducted or what the results were.

The article also mentions the study that found that the supplement resulted in increased brain size & dendritic growth in rats.

So although the emailer may be a quack who makes spelling mistakes, he is in fact referring to some real information.

I appreciate debunking of quackery — it’s a primary reason I read scienceblogs — but perhaps at least scanning the first page of google results is in order first?

It is currently underway, at the University of Calgary. It is a clinical trial has been approved by the Ethics Committee at the University of Calgary (Conjoint Health Research Ethics Board), as well as by Health Canada.

This is a “quack back”. Common courtesy would have dictated a personal reply and an expression of your skepticism. Instead you chose to display both your ill-manners and your ignorance. What a surprise (not!)

Interested researchers who wish more data (and aren’t blind to the obvious) are encouraged to contact Dr. Charles Popper, professor of childhood and adolescsent psychopharmacology, Harvard Medical School. Dr Bonnie Kaplan, University of Calgary. Dr Brian Kolb, University of Lethbridge.

I believe it was Schopenaur who fist articulated the trajectory of “new” theories. First they are ridiculed, then they are violently opposed, finaly they are accepted as self evident.

As a relevent aside, it is worth noting that very few double blind placebo controled trials which are used to get market approval for most psych meds demonstrate better efficacy than placebos( and usually have body/soul detroying side effects). Further most of new anti-psychotics are prescibed for off label indications.

Any fool with a passing understanding of cellular metabolism, recognizes that you are what you digest (not what you eat). I suggest you do some reading on how the human body manufactures peptides and their role in emotional states and how cells reproduce and favor the receptors on their “copies” to which they are most exposed.

“Care to give a link that goes somewhere other than a site recruiting for this “study”?”

Um, I don’t know anything more about it. I’m not connected with it in any way. I merely found it because I was curious.

But now I’m really curious. Why the scare quotes around study? It’s a clinical double-blind study, being supervised by a research scientist at a University, it’s purpose and methodology duly approved by the University and by Health Canada.

Why the scare quotes? I don’t get it.

I totally get mocking obvious quackery. And if there is something inherently quacky about the hypothesis — that violent mood swings may indicate that the biology or neurochemistry of the individual is such that a diet that would provide sufficient vitamins and minerals for an ordinary individual results in deficiencies that contribute to those violent mood swings — I would like to know what it is. On the face of it, it does not seem like an inherently quacky hypothesis. There is some known circumstantial evidence to support it — the prison studies, the thiamine study, the selenium study.

Why should it not be studied?

Why should the person studying it be subjected to ridicule for daring to study it?

Why should it be implied their study is not a “real” study?

If you have some good reasons why the idea is inherently quacky, I would genuinely like to know what they are. I’m not trying to pick a fight or say you are wrong. You seem to have information that I, a layperson, do not. I would like to know what it is so that I can add it to my quackery-detecting toolbox if I deem it reasonable.

If there are clinical trials being conducted at the moment, then it’s very irresponsible of TrueHope to market and sell the product before the results are in.

I understand that EM Power+ is actually classified as a drug and not as a nutritional supplement. I also understand that, several years ago, shipments of the product were being stopped at the Canadian border, and that TrueHope has had a number of lawsuits brought against them by people who suffered from adverse effects after taking the supplement.

Woooo! First, the hypothesis is a little odd,but sure…test it. Just don’t push the product without first conducting the study!

“Any fool with a passing understanding of cellular metabolism, recognizes that you are what you digest (not what you eat). I suggest you do some reading on how the human body manufactures peptides and their role in emotional states and how cells reproduce and favor the receptors on their “copies” to which they are most exposed.”

“Common courtesy would have dictated a personal reply and an expression of your skepticism. Instead you chose to display both your ill-manners and your ignorance.”

I’m not sure which common courtesy dictates that. However, given that you could send that email to many people, not just Mo, it seems that the right thing to do would be to broadcast his response to everyone, thus reaching everyone who you might have emailed it to. A private discussion between the two of you will not do anything to educate the public.

Mo also did not attack you or the product in an unfounded manner. He stated clearly what research has been done on it and from that stated what kind of marketing a company should be ethically allowed to perform. Again, not attacking you or stating that the product does not work.

“Any fool with a passing understanding of cellular metabolism, recognizes that you are what you digest (not what you eat). I suggest you do some reading on how the human body manufactures peptides and their role in emotional states and how cells reproduce and favor the receptors on their “copies” to which they are most exposed.”

I’m not sure exactly what your point here is. So your body uses what you eat to manufacture peptides? How does that make A) this product any safer B) suggest it has any effect on bipolar disorder? How does any of what you said suggest some random product has the desired effect? If determining the safety of a drug and efficacy is so simple as to understanding “what you eat manufactures peptides” then the FDA is causing a lot of clinical trials, time, and money spent for nothing.

In fact Truehope is under court order to continue selling the product. In their criminal trial (not clinical) last summer the judge ruled they would be liable for criminal negligence if they stopped selling the product.

The Crown had 30 days to appeal the Provincial court ruling and chose not to. I am unaware of any civil actions against Truehope and am aware of thousands of letters of support from users of their product. (see healthcanadaexposed.com)

Most of the on line ranting about the “dangers” of the product come from the discredited “wannabe” Dr. Terry Polevoy, a yank pediatrician who for some reason runs an acne clinic in Kitchener Ontario.

In one of those ironies you couldn’t possibly make up, the author of the Calgary Sun stories on the trial Licia Corbella is an advisor to Calgary based think tank, the Manning Centre for Building Democracy, along with Canada’s Minister of Health Tony Clement. Lest you think so what, the Manning Centre was founded by Preston Manning, twice Canada’s leader of the Opposition. Mr. Manning’s protege, Stephen Harper, is now our PM.

For the politicaly inclined, research your Hansards and read the debates about how the use based definition of “drug” ever became law in your food and drug acts.

“In fact Truehope is under court order to continue selling the product. In their criminal trial (not clinical) last summer the judge ruled they would be liable for criminal negligence if they stopped selling the product.”

Had I wished to be shilling, I would have posted. Instead I sent you a personal email, thinking that given your thoughts in your post on “augmented cognition” you would find it interesting. I had no commercial intent.

Without exception, every researcher who has given the protocol a fair shake has been amazed. The founders of the Truehope group are both devout Mormons (with large families) who personaly experienced the pain of mental illness in their lives. Desperation drove them to discovery after one lost his wife to suicide and their children started exhibting the symptoms (Standard psychiatric care failed them). These are people of deep faith and pure heart and I am honoured to be considered their friend. BTW, I take the product for the simple reason that it makes me a better human. I think better lateraly (do far better at NYT daily crossword)I am a better father and more patient with my kids. I work in a pressure cooker and it used to be easy to blame other for my own “stinking thinking”. I now maintain a far more even keel.

I feel tough for PaLMD. He’s going to be so disappointed when his Big pharma pals finish cashing out and the field is left to BIG food and little pharma and he is forced to deal with a world where informed citizens who are sovereign over the bodies are “allowed to make informed choices”… as long as those choices are limited to ADM, Cargill, Monsanto, Roche Crop science, etc. products (all patented of course)

I suspect many of the readers of this blog are independant thinkers and see through his self serving pomposity.

I suggest any who are curious investigate exactly why the cost to market for products is so high and how the current system evolved. For any who wish to learn the evidence is easy to ferret out. K Street lobbyists in DC, funded by Wall St. financial interests in NY, sugar coated with the best Maddison Ave. pig-lipstick appliers money can buy, enforced by a bought and paid for FTC and FDA have excelled for years at crushing threats to their chokehold on the medical monopoly. Mainly with regulatory burden. “How dare you feel better, by changing your lifestyle and diet. You’re not cured till I say so.” In spite of this modern medicine remains at, or near the top of the heap when it comes to killing the public. (With the very notable exception of emergency medicine, which only a fool would want to do away with.)

As a heads up, I’ll let you know that Canada’s top health bureaucrat is an expert in intellectual property and his new assistant is an expert in international agricultural trade policy. The future is easy to read if you know what signs to look for…biotech anyone?

What woo-qat have you been chewing?? What makes you think I have anything to do with “big pharma”? What makes you think I don’t favor lifestyle modification?
I think if anyone here has a dishonest agenda it would not be me. I prescribe mostly generic medications (average cost $4 a month) for my patients who need medications, and I prescribe meds and lifestyle mod based on EVIDENCE. I don’t own any stock, or have any other investment in the industry.
Feel free to stay away from modern medicine…just don’t spread your gospel to unsuspecting victims.

Your argument coming back around to big pharma being evil and screwing over the average man does not help your case. I see this all the time on science blogs, it’s generally a symptom of being a nut. I’m not saying you are a nut but spouting the whole “big pharma is evil” and they are specifically out to ruin normal peoples lives with misinformation and lies does not help your cause. You sound to suffer from the “if it’s not a perfect system it must be wrong” failed logic when it comes to pharma. I’m sorry, but the human body really IS more complex than “you are what you digest” and that is why finding drugs that work is so difficult. If you don’t think that the human body is more complex than this then it would guess you are just living in a dream world. Take some medical classes or something to see what the reality is instead of spreading naive thinking on a blog.

I apologize for monopolizing your blogspace. I just can’t stand quackery, as it gets in the way of actually treating human beings. Medicine has advanced so far in the last 30 years that it is hard for the average person to comprehend. Advancements in heart disease, in particular, and the medical treatment of it, save and improve hundreds of thousands of lives. This is based on actual evidence…randomized controlled trials. And it is not based on the most expensive meds. The four main classes of drugs used to treat heart disease (beta blockers, aspirin, ace inhibitors, and statins) can be purchased at WalMart for a total of 15 dollars a month. It isn’t about the money…it’s about lives. Ask me for a reading list…I’ll be happy to provide it.
But don’t tell me that expensive woo is the answer to everything…at least not without actual de-wooifying evidence.

Well, I guess it was too much to hope that Peter would either come out and admit he advertises woo, or try to get some legitimate evidence. I posted my mini-critique at my place to avoid stealing bytes from our generous host here.

I’m writing from Calgary. Outside my office, I have a patient recruiting poster for this study, but I have nothing to do with the study.
My own viewpoint is that perhaps this compound could be helpful (just as a ketogenic diet helps reduce seizure frequency for some people), and a double-blind study is the best way to assess it. Some of the academics involved, such as Bonnie Kaplan and Bryan Kolb, are highly respected for their academic work in psychology and neuroscience. But note they didn’t come on till after the product was being sold.
I think it was risky and irresponsible to promote and sell this product before doing these tests. That’s nothing to do with big pharma, but is everything to do with promoting a compound that has unkown risks, benefits, and interactions. In the hospital cafeteria, 50 yards down from this recruiting poster, is a sign warning patients that cranberry and grapefruit juice can affect medication metabolism, and urging patients to discuss this with their doctors.

If this combination works, great. But we need to know if it works, what and who it works for, and what risks there are. Otherwise, it is just quackery (or perhaps more accurately, it’s unapproved and uncontrolled medical experiementation without anyone keeping track of the results).

So to clarify, the clearest route to de-woo-ification would be to do a randomized controlled trial of the substance in question, with a sample that is large enough to provide statistical power, and is representative enough for the results to be generalized to a larger population. The stats should be done well, the study should be double blinded or crossover, it should use an intention to treat analysis…wait..does this sound hard?
Guess what? Science is a lot harder than woo. But it also works better. I’d rather get in a plane designed by an engineer than by some guy who says, “it looks like its gonna fly…one guy said it did.”

I agree 100% that the product should be properly studied. As to how risky & irresponsible it was to market the product before it was studied, a couple factors need to be taken into consideration:

1) from the Discover article, it seems that the makers made a concerted effort to drum up some interest in third-party studies, but were mostly responded to by people like PalMD on autopilot. Not only that, but apparently when the two scientists who did decide to have a look published their preliminary results, they too were greeted with the sort of automatic derision exhibited by PalMD. This pisses me off almost as much as obvious snake oil shilling does.

2) No claim to secret ingredients or a special unique un-reproducible secret formula (the hallmarks of snake oil) is made by the makers.

3) All ingredients are listed, and the product is essentially a multi-vitamin with higher than normal dosages of many of the minerals. Not only do the makers not try to disguise that in any way, it is core to their theory of why they believe it works. I understand that it is nonetheless true that some of these high doses of vitamins/minerals may have adverse side effects, hence the necessity for studying both efficacy & safety.

PalMD is apparently some kind of “doctor” with some sort of “background” in what he likes to call “science.”

If the scare quotes in that sentence offend you, PalMD, you might want to rethink your use of them to characterize a study being performed by a respected researcher at a University in full compliance with both their University’s and Health Canada’s standards for clinical studies.

I wonder what was wrong with the lightest metal, Lithium, the present remedy for MDP(manic depressive psychosis or bipolar disorders). A serendipitous discovery by Cade, an Australian,the salt of this drug used to be given instead of salt, when calming effect was observed incidentally.

I take no offense at your scare quotes. You don’t know who I am, so you have no reason to trust me beyond what I write, and I’m willing to be judged on that.

Snake-oil doesn’t have to have secret ingredients, at least by my definition of woo. It just has to be marketed to do something as yet unproven. If this were 30 years ago, and someone tried to sell me beta blockers for my CHF patients, I’d tell them no way, prove it. Well, they did.
Now it’s your turn.

You keep responding to me like I’m a shill for the product. I’m not. I also believe the product ought to be studied before it is sold.

I’m not trying to convince you to support an unstudied product. I’m trying to get you to explain why you feel the need to ridicule the idea of studying it, ridicule the study being done, and ridicule the scientists doing the study.

I have a hypothesis for why you chose to sneer not only at the purported snake oil but at the idea of studying it and at the study itself: because your skeptical response is not a true skeptical response — arrived at by examining a claim and the evidence for it and coming to a conclusion about whether the claim is worthy of further study by using your existing knowledge and some critical thinking — but rather just kneejerk skepticism. An opportunity to enjoy a shared experience with your peer group by mocking something and goading the quacks who come out of the woodwork to defend it.

Now this would be perfectly fine if the claim were something that could easily be rejected prima facie — shoe magnets for example. In this case, however, the claim can not be rejected prima facie, was developed by analogy to an effect known to exist in animals, and has substantial anecdotal and circumstantial evidence that would seem to warrant its being studied further.

It’s a shame, because in many other comments of yours that I’ve seen you come across as quite intelligent & dedicated.

In my opinion, kneejerk skepticism can sometimes be nearly as deleterious as quackery with respect to retarding progress. This is a good example of that: where two real scientists, with real credentials, did real preliminary (ie, case series) examinations of a claim, published, and were responded to with such a wave of kneejerk skepticism — based purely, so far as I am able to determine using google, on the source of the claim they were examining — that they were reluctant to be involved in studying it further.

Luckily, it seems that despite the reactions of the PalMDs of the world, one of those real scientists has decided to go ahead and study the claim further, so it looks like it will get examined more deeply and we will eventually get to find out whether or not the crazy people who took Health Canada to court all the way up to a Supreme Court decision to ensure continued access to the product were doing so on the strength of something more than the placebo effect.

My ridicule is reserved for those who are trying to sell, premote, or otherwise shill for a product whose premise is to sell before testing. That is called woo.
No one, nowhere shoud make any claims about this stuff until it is properly tested. Meanwhile, websites are selling this stuff, pretending you are joining some sort of study. I’m pretty sure it’s criminal down here beneath the 48th.

“You keep responding to me like I’m a shill for the product.”
–Because you are acting like it.
I’m not. I also believe the product ought to be studied before it is sold.
Good. So continue to make that explicit.

I’m not trying to convince you to support an unstudied product.

I’m trying to get you to explain why you feel the need to ridicule the idea of studying it, ridicule the study being done, and ridicule the scientists doing the study.
-Im ridiculing the whole idea…a product being aggressively promoted without existing evidence. It should be taken off the market, shelved, and not see the light of day until real evidence exists.
The hostility comes in because it separates ill people from real treatment and from their money.

As someone with bipolar, can I send out a “WOOT!” to the people who think it’s ok to market drugs without testing to people like myself who might be desperate for something that works? it’s just my brain you might be messing with.

I believe I saw a blurb about this in Canadian Living awhile back, and I was a little bothered by the almost blind faith. If the studies are conclusive, then awesome! but until then….I really would like there to be more focus on the drugs that do work for some of us.

this is also a lie. You have, and are, explicitly ridiculing a research scientist with no connection to the marketing of the product, and her University of Calgary & Health Canada approved study.

Not only ridiculing her, but trying to make the absurd and offensive claim that her website is a front to sell the product.

You are offering no reason why. I understand very clearly the reasons for not marketing products that have not been studied for their efficacy & safety and I agree with them.

What offends me is that now here there IS A SCIENTIST DOING A STUDY and it is that that you are ridiculing & dismissing. WHY?

Is it because she’s a woman?
Is it because the University is in Canada, ie, a furrin’ country?
Is it because the hypothesis she is studying did not come from a large pharmaceutical company?

What is your actual critical-thinking based reason for your derision of the study of the product? Not of the fact that originally the product was marketed without being studied — I’ve said about 50 times already I understand and agree with that. What is your evidence-based reasoning behind rejecting and ridiculing the fact that IT IS BEING STUDIED now????????

“It should be taken off the market, shelved, and not see the light of day until real evidence exists.”

For real evidence to exist, it would have to be studied. Why then is the idea of studying it such an anathema to you, and why do you feel compelled to ridicule the actual study that is actually underway?

This makes absolutely no sense to me, except in the context that you have decided to take an attitude not of “prove it to me” as you claim, but rather of an outright rejection of the hypothesis on which the product is based without critically examining it, for no good reason other than as a kneejerk response.

I should mention that to be honest my initial instinct about the moodstudy website was the same as yours, that it would be a front for selling the product.

However, unlike you, rather than blindly listening to that instinct — which is purely an emotional response if you are honest enough to admit that to yourself — I relied instead on investigating. I did a whois. I did a google. I read through the site. And I contacted the author of the site with a question about the study and received an answer from Bonnie Kaplan, the research scientist doing the study, from her official Calgary Health Region email address.

Doing this allowed me to have an information-based opinion about what the moodstudy site is. It is in fact a site to recruit participants in an independent, officially sanctioned clinical trial.

That you did none of this but felt comfortable posting in a public place your gut feeling about what the site was as though it were fact tells me a lot about you, and confirms my opinion of you as more of a kneejerker than a critical thinker.

I was curious about the idea that a judge found that Truehope was “legally obligated” to continue selling the product after being cited by Health Canada, as mentioned earlier in the thread by Peter Helgason

The “legally obligated” idea refers to the fact that the judge found that Truehope could “rely on the defence of necessity”, ie, that they could not stop selling the product despite being ordered to do so by Health Canada because of people whose continued health depended on access to the product.

(please note, I am not stating that people’s health depended on the product as my own opinion. It was the defence used by Truehope, and the judge found in favour of it)

I’m not sure what Soggy thinks I said. I never said that it shouldn’t be studied.
I did follow the links (perhaps different from the ones you followed), and found the product being sold, with the deceptive tag line of calling it a study. I suspect that that site is not the same as the one attached to an actual clinical study.
I’m sure you and I agree on many things, but are just passing by each other on our comments.
The basic point I make is that this product should be available ONLY to researchers, and anyone else selling it with health claims should be ashamed.

“In fact Truehope is under court order to continue selling the product. In their criminal trial (not clinical) last summer the judge ruled they would be liable for criminal negligence if they stopped selling the product.”

IANAL, but I’m pretty sure that this is quite an exaggeration. The judge found that Truehope’s defence of necessity was plausible, enough so to dismiss the case brought by Health Canada (in conjunction with the finding that the rules under which Truehope was being prosecuted were inappropriately defined, and had subsequently changed).

This is not anything like a court order to continue selling the product, nor is it a finding that Truehope would be criminally negligent if they stopped selling the product. It is only a finding that that idea is plausible enough to serve as a defence against being prosecuting FOR selling it.

I’m having trouble finding out for sure if the product STILL is against Health Canada’s new rules for health foods. I believe it is because of the inclusion of small amounts of boron & germanium, which are not yet approved in Canada as nutritional supplements.

The point I think SoG is missing is that it’s being sold NOW, before the proper evidence is available. Do you see why that’s a problem, SoG?

That fact, taken in conjunction with the claims of conspiracy, name checking of ancient philosophers, and allegations of being an idea too far ahead of its time, means that it scores pretty high on the crackpot scale without even considering the company and product naming.

“The point I think SoG is missing is that it’s being sold NOW, before the proper evidence is available. Do you see why that’s a problem, SoG?”

Jeez, I just managed to state over and over again in almost every post I made that I understand and agree with that concept. I wonder if I see it.

Do you understand why I think it is a problem that an idea based on a reasonable hypothesis with circumstantial evidence to substantiate it should be mocked with complete derision, and aspersions about their motivations cast on the scientists who do decide to go out on a limb and do the proper studies?

No one, despite my repeatedly asking, has provided any good reason why the idea behind the product should be rejected prima facie (as one can, for example, with shoe magnets etc.) as it apparently was when the developers of the product made the rounds of Universities attempting to get the stuff studied as it should be.

That my concern. At the beginning of the discussion I’d never heard about the product, and I’m not in its target audience so I have no vested interest. My curiosity was merely piqued by the vitriolic derision being heaped on it, with, it seemed to me, no good substantiation.

And after the discussion, in the complete and deafening absence of reasons for rejecting the hypothesis behind the product from those posters who by their background supposedly would have such knowledge, I feel that in fact the idea of the product (not the fact that it is being marketed with untested health claims and continues to include one ingredient for which the safety is unverified — and please, let me just state ONCE MORE I understand and agree it ought not to be) is being rejected largely because of its source. Because it came from pig farmers & not a pharmaceutical company. This is neither proper skepticism nor critical thinking. It is kneejerking.

I’m making a distinction: between the marketing of the product, and the hypothesis behind the product.

I feel others are not making that distinction, but are instead using the well-accepted tropes about the improperness of marketing of the product before fully tested, to justify rejecting and deriding the whole idea of the product, and to cast aspersions on the scientists studying it.

Well after reading the many comments upon this e-mail I have been convinced of my theory about why chronic disease is getting worse not better. The lack of open-mindedness to approaches that may be very non-invasive and help others is quite appalling. Every human has the right to freedom and it is highly arrogant to believe that the small brain that you operate from could possibly be more superior than any other brain on the planet and that only your fixed view of how a study must be performed is the way. Do you even realize who wrote your text books? Why don’t you spend the better parts of your days looking into who stands to gain by certain pieces of information becoming mainstream and who stands to gain by you vehemently fighting something you have not been trained to understand.
This is by no-means a put down or intended to be so. I have spent the better parts of my days like yourselves conducting research and if you look at the top of the information ladder you will see that there is mountains of information on both sides of this debate. My next question then would have to be…Who has the most to lose or gain.
Whenever information is put out one has to open his view and look to all sides of the arguments to see not just what facts are presented but if the facts are even true or if someone had a reason for facts to be presented in such a way as to benefit from people believing it.

Since this is well-being and health we are talking about in the medical field how about we stop seeing others as a chance to prove to the world that we are right and work to find common solutions that are working for patients.

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